UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031321 |
|---|---|
| Receipt number | R000035613 |
| Scientific Title | Phase I/II trial of percutaneous vertebroplasty combined with radiotherapy for vertebral metastasis |
| Date of disclosure of the study information | 2018/02/15 |
| Last modified on | 2022/08/21 09:32:17 |
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Basic information
Public title
Phase I/II trial of percutaneous vertebroplasty combined with radiotherapy for vertebral metastasis
Acronym
Phase I/II trial of PVP+RT for vertebral metastasis
Scientific Title
Phase I/II trial of percutaneous vertebroplasty combined with radiotherapy for vertebral metastasis
Scientific Title:Acronym
Phase I/II trial of PVP+RT for vertebral metastasis
Region
| Japan |
Condition
Condition
vertebral metastasis
Classification by specialty
| Hematology and clinical oncology | Orthopedics | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of percutaneous vertebroplasty combined with radiation therapy for vertebral metastasis with symptomatic skeletal events
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
To evaluate short-time safety of percutaneous vertebroplasty combined with radiation therapy for vertebral metastasis with symptomatic skeletal events
Key secondary outcomes
To evaluate safety and efficacy of percutaneous vertebroplasty combined with radiation therapy for vertebral metastasis with symptomatic skeletal events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Percutaneous vertebroplasty
Radiation therapy 30Gy/3fr/10times, 20Gy/4fr/5times, or 8Gy/1fr/1time
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)The terget lesion was diagnosed as vertebral metastasis.
2)The terget lesion was thoracic or lumber vertebrae.
3)The number of terget lesions was within 3.4)Bilsky Grade >= 1b
5)Patient has pain from the lesions under analgesic.
6)SINS >= 7 or SINS <= 6 and meet the below.
a)Lytic lesions with > 1/3 vertebral body involved
b)Lytic lesions with pain in mortion
c)Lesions with vertebral collapse
7)The period of prognosis > 3 month
Key exclusion criteria
1)Patients can not maintain the position needed for treatment
2)Target lesions is cervical vertebrae or sacrum
3)The number of terget lesions was more than 4.
4)Bilsky Grade >= 1c
5)History of radiation therapy or surgery for target lesions
6)Bleeding tendency (Platelet counts <= 50,000 or PT-INR > 1.5)
7)Spondylitis or discitis
8)History of major drug allergy
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Okada |
Organization
Kobe University Hospital
Division name
Department of Diagnostic and Interventional Radiology
Zip code
6500017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6104
okataku@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Okada |
Organization
Kobe University Hospital
Division name
Department of Diagnostic and Interventional Radiology
Zip code
6500017
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6104
Homepage URL
okataku@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital
Address
7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel
078-382-5111
kainyu@med.kobe-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 15 | Day |
Last modified on
| 2022 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035613
